Rheumatoid ArthritisNCT03843619
Electronic and Lab Pre-screening of New Rheumatology Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Inflammatory Arthritis, run by Arthritis Northwest PLLC.
Trial summary
By forming the foundation of a delivery system that integrates primary care (PC) and rheumatology, this initiative strives to strengthen the roles of both primary care and rheumatology practices as they co-manage patients in a quality care delivery system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Inflammatory Arthritis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2019to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred to a rheumatologist for inflammatory arthritis.
Who may be able to join
- First ever referral to a rheumatologist.
Who cannot join
- -
About this study
Official title: Electronic and Lab Pre-screening of New Rheumatology Patients
By forming the foundation of a delivery system that integrates primary care (PC) and rheumatology, this initiative strives to strengthen the roles of both primary care and rheumatology practices as they co-manage patients in a quality care delivery system. Importantly, it strives to fill an unmet need, the rapid evaluation by Primary Care providers; the appropriate and timely referral of inflammatory disease patients to a rheumatologist; and the implementation of early aggressive therapy in the management of patients with rheumatoid arthritis (RA) with tight control. Given the call for improved quality, value, and demonstration of results[1], this initiative uses the tenets of National Center for Quality Assurance's Patient Centered Specialty Program[1] (PCSP) and it successfully masters and streamlines coordination of care.
- Conditions
- Rheumatoid Arthritis, Inflammatory Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-E-referral | Patients who are referred in the traditional manner between two separate organizations. | |
| E-referral | Patients who are referred in an automated manner between two separate organizations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To increase referral efficiencies through an electronic system to decrease the timeline prior
Mean and median time (in days) to the first rheumatology visit from PCP referral for both cohorts
Measured: One year enrollment period
Secondary outcomes (3)
To assess difference in disease activity progression using Clinical Disease Activity Index (CDAI) at both 12 and 24 months.
The change in CDAI score from baseline at 1 and 2 years. CDAI uses a scale of 0 - 60 where scores less than 2.8 are considered "remission", 2.9 - 10.0 are "low" disease activity, 10.1 - 22.0 are "moderate" disease activity, and 22.1 or higher are "high" disease activity.
Measured: One year enrollment period with two year follow-up period.
To assess difference in disease activity progression using Routine Assessment of Patient Index Data (RAPID3) at both 12 and 24 months.
The change in RAPID3 score from baseline at 1 and 2 years. RAPID3 uses a scale of 0 - 30 where scores less than 3.1 are considered "remission", 3.1 - 6.0 are "low" disease activity, 6.1 - 12.0 are "moderate" disease activity, and 12.1 or higher are "high" disease activity.
Measured: One year enrollment period with two year follow-up period.
To assess radiographic progression using sharp scores in the electronically referred cohorts versus the traditional cohort.
The change in sharp scores from baseline at 1 and 2 years.
Measured: One year enrollment period with two year follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start28 Feb 2019 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arthritis Northwest PLLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb, Discus Analytics LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843619
- Sponsor's protocol ID
- R-17015
- Status last verified
- Feb 2019
- First submitted
- 22 Jan 2019
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic and Lab Pre-screening of New Rheumatology Patients
- ClinicalTrials.gov ID
- NCT03843619
- Acronym / sponsor ID
- R-17015
- Conditions
- Rheumatoid Arthritis, Inflammatory Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Arthritis Northwest PLLCIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb, Discus Analytics LLC
- Study start
- 28 Feb 2019 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
By forming the foundation of a delivery system that integrates primary care (PC) and rheumatology, this initiative strives to strengthen the roles of both primary care and rheumatology practices as they co-manage patients in a quality care delivery system. Importantly, it strives to fill an unmet need, the rapid evaluation by Primary Care providers; the appropriate and timely referral of inflammatory disease patients to a rheumatologist; and the implementation of early aggressive therapy in the management of patients with rheumatoid arthritis (RA) with tight control. Given the call for improved quality, value, and demonstration of results[1], this initiative uses the tenets of National Center for Quality Assurance's Patient Centered Specialty Program[1] (PCSP) and it successfully masters and streamlines coordination of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-E-referral | – | –Patients who are referred in the traditional manner between two separate organizations. |
| E-referral | – | –Patients who are referred in an automated manner between two separate organizations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to a rheumatologist for inflammatory arthritis.
Key inclusion criteria (1 listed)
- First ever referral to a rheumatologist.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To increase referral efficiencies through an electronic system to decrease the timeline prior
Time frame: One year enrollment period
Mean and median time (in days) to the first rheumatology visit from PCP referral for both cohorts
3 secondary outcomes
To assess difference in disease activity progression using Clinical Disease Activity Index (CDAI) at both 12 and 24 months.
Time frame: One year enrollment period with two year follow-up period.
To assess difference in disease activity progression using Routine Assessment of Patient Index Data (RAPID3) at both 12 and 24 months.
Time frame: One year enrollment period with two year follow-up period.
To assess radiographic progression using sharp scores in the electronically referred cohorts versus the traditional cohort.
Time frame: One year enrollment period with two year follow-up period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Inflammatory Arthritis, run by Arthritis Northwest PLLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To increase referral efficiencies through an electronic system to decrease the timeline prior (time frame: One year enrollment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.